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The goal of study is to evaluate the effectiveness of adipose tissue derived-MSCs concentrate application in mandibular fractures. The main question it aims to answer is: Does intervention enhance bone quality, reduce complications and reduce bone regeneration time.
Researchers will compare the effectiveness of adipose tissue derived-MSCs concentrate application with ORIF to ORIF alone to see if MSCs improve healing in mandibular fractures.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 10 patients with mandibular fracture will be treated by application of adipose tissue derived MSCs concentrate on fracture line before and following fixation with titanium plates and screws. |
|
| Control group | Active Comparator | 10 patients with mandibular fracture will be treated by open reduction and internal fixation with titanium plates and screws. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation. | Procedure | Abdominal fat liposuction will be carried out, microfragmentation of adipose tissue will be performed. Then the filtrate containing mesenchymal stem cells concentrate will be applied to the fracture line before and following fixation with titanium plates and screws . |
| Measure | Description | Time Frame |
|---|---|---|
| Bone density | Assessment of bone density at fracture healing site by CBCT | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Soft tissue dehiscence | Detection of soft tissue dehiscence occurrence (Binary: Yes/ No) | 3 month |
| Bleeding | Detection of bleeding occurrence (Binary: Yes/ No) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mona Mahmoud Abdulhameed | Contact | 00201001249384 | monamabdulhameed@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mostafa Mohamed El-Gangehi, Professor | Faulty of Dentistry, Cairo University | Study Chair |
| Walaa Kadry, Associate Professor | Faulty of Dentistry, Cairo University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27513920 | Result | Castillo-Cardiel G, Lopez-Echaury AC, Saucedo-Ortiz JA, Fuentes-Orozco C, Michel-Espinoza LR, Irusteta-Jimenez L, Salazar-Parra M, Gonzalez-Ojeda A. Bone regeneration in mandibular fractures after the application of autologous mesenchymal stem cells, a randomized clinical trial. Dent Traumatol. 2017 Feb;33(1):38-44. doi: 10.1111/edt.12303. Epub 2016 Sep 13. |
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|
| Open reduction and internal fixation | Procedure | Open reduction and internal fixation of fracture line with titanium plates and screws |
|
| 3 months |
| Infection | Detection of Infection occurrence (Binary: Yes/ No) | 3 months |
| Malocclusion | Detection of malocclusion occurrence (Binary: Yes/ No) | 3 months |
| Sameh Mekhemer, Professor |
| Faulty of Dentistry, Cairo University |
| Study Chair |
| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D000070799 | Open Fracture Reduction |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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